Title: P1252428697Wuzfe
1European Voice Conference Chemicals and
consumers a question of confidence Dr.
Matthias VeyInternational Fragrance
Association Tuesday December 4, 2007 Renaissance
Hotel Brussels, Belgium
2Preparing for REACH
Common household fragrances may be harming
aquatic wildlife, study finds Stanford New
Service October 2004
A Whiff of Danger Synthetic Musks May Encourage
Toxic Bioaccumulation Environmental Health
Pespectives January 2005
Environment group raises stink over perfumes
Agence France Presse 10 February 2005
Valentine perfume 'can make you sick' The
Guardian 11 February 2005
Study on Air Fresheners - BEUC Hits Back BEUC
Press Release February 2005
Greenpeace Study Critical of Some Fragrances
Womens Wear Daily 14 February 2005
Phthalates and Artificial Musks in Perfumes
RI-A R 2005/011 TNO-Report Greenpeace
January 2005
MY TOXIC VALENTINE GREENPEACE FINSD SUSPECT
CHEMICALS IN PERFUMES
3Growth of the Scare Industry
- Excessive public campaigns
- Lead to increasing consumer mistrust.
- Result even in loss of materials that have been
declared safe by numerous scientific institutions
like DEP (Diethyl phthalate), sacrificed by the
industry due to pressure by the misinformed
consumer, scared by non-differentiating
phthalate campaigns - Become worse by advances in analytical chemistry
(Relevance of finding 0.000000000001 of a
material in blood, mothers milk or the
environment?). - May result in regulatory activities that tend to
be based on hazard identification instead of risk
assessments - potentially leading to unnecessary
constraints danger of misusing the
precautionary principle
Toxic bathroom
Toxic Valentine
Air fresheners cause a stink
4Where is this leading to ?
5Synthetic versus NaturalA twisted debate
- Chemo phobia fuelled by certain interest groups
leads to strange consumer expectations - Natural is generally regarded safe chemically
derived (synthetic) as unsafe - Naturals are per se neither more safe or less
safe than synthetic materials a number of very
potent toxins are naturally derived (think about
the fugu in Japan) one of the strongest
fragrance sensitizers is a natural extract
6Vanilla Flower
Many chemicals used in modern perfumery were
developed between 1850 and 1910. Many
chemicals (so called aroma chemicals are
derived from the study of natural products. One
example is vanillin
Naturals
Fresh Vanilla pods
Synthetics
Dried Vanilla pods
7Role of (Aroma) Chemicals
RECONSTITUTION
ORIGINALITY
Lily of the Valley
SUBSTITUTION
ECOLOGY
Musk deer, an endangered species
8Synthetic versus NaturalA twisted debate
- If our industry wanted to provide fragrances only
consisting of natural materials (like e.g. rose
oil), they would be prohibitive for most of the
consumers due to the price but would they be
more safe? - Basis for a decisions about the safety of an
ingredient (synthetic as well as natural) is a
sufficient set of data that allows a safety
(risk) assessment
9Who cares about fragrance safety!?
- Industry self-discipline versus regulation?
- to ensure the safe use of fragrance ingredients /
fragrance compounds - Stakeholders involved Sensitive points
- Regulators, Media, Adequate Science
- NGOs, Dermatologists Compliance - Control
- Consumers, Distributors Sufficient independence
- more
- The fragrance industry has a research program in
place since more than 40 years and maintains a
global regulatory system with the objective of
protecting consumer health and the environment
since 1973 - IFRA Self-regulation is fast, global and
independent!
10REXPAN Independent Panel of Experts
Hachiro Tagami, MD Tohoku Univ. School of
Medicine, Sendai, Japan
Jon M. Hanifin, MD Oregon Health Sciences
Univ. I. Glenn Sipes, PhD. (Chair) University of
Arizona Donald V. Belsito, M.D.Univ. of
Missouri David R. Bickers, MD Columbia
University, NY Adrianne E. Rogers, MD Boston
Univ. School of Medicine
- Prof. Magnus BruzeMalmo University Hospital,
Sweden - Prof. Peter CalowRoskilde University, Denmark
- Prof. Dr. Helmut A. Greim
- Neuherberg Institut für Toxikologie
- Munich, Germany
- Jean-Hilaire Saurat, MD
- Universitaire de Geneve, Switzerland
11Fragrance Industry Safety Program
- Build on two pillars
- RIFM Research Institute for Fragrance
Materials - RIFM and its Expert Panel REXPAN are responsible
for safety testing and risk assessmentwww.rifm.or
g - IFRA International Fragrance Association
- IFRA is responsible for the risk
managementvia the IFRA Code of Practice and
Standards for safe use of fragrance ingredients - www.ifraorg.org
12Perfumers dispose of approximately 2000
ingredients both natural and synthetic, with
which to create fragrances.
13Complexity of the fragrance
The formula used in the manufacturing plant
First level
Full composition
Natural
Synthetic
Natural
Base
Natural
Natural
Synthetic
Natural
100 to 800 ingredients
Synthetic
Synthetic
Synthetic
Synthetic
Base
Natural
Base
Synthetic
The formula used for the risk assessment,
labelling, etc
14DOWNSTREAM USE OF FRAGRANCE SUBSTANCES
USE REACH PRE-REGISTER REGISTER CHEMICAL SAFETY REPORT If gt 10 t/y per Legal Entity CHEMICAL SAFETY REPORT If gt 10 t/y per Legal Entity CHEMICAL SAFETY REPORT If gt 10 t/y per Legal Entity CHEMICAL SAFETY REPORT If gt 10 t/y per Legal Entity
USE REACH PRE-REGISTER REGISTER SUBSTANCE SAFETY ASSESSMENT .. and If . SUBSTANCE CLASSIFIES AS HAZARDOUS then ALSO Exposure Assessments for .. and If . SUBSTANCE CLASSIFIES AS HAZARDOUS then ALSO Exposure Assessments for .. and If . SUBSTANCE CLASSIFIES AS HAZARDOUS then ALSO Exposure Assessments for
USE REACH PRE-REGISTER REGISTER SUBSTANCE SAFETY ASSESSMENT CONSUMERS WORKERS ENVIRONEMT
COSMETICS (Dir. 76/768/EEC) always always NO, except YES for indirect exposure via environment YES, for ALL production compounding formulation YES, for ALL production compounding formulation FINAL FATE
NON-COSMETICS Household cleaners Airfresheners Articles, e.g. candles always always always always always always always always YES, for ALL direct indirect exposures YES, for ALL production compounding formulation YES, for ALL production compounding formulation FINAL FATE
FLAVORS For Food For Oral Care ( cosmetics) NO always NO always NO YES, as for Cosmetics NO YES, as for Cosmetics NO YES, as for Cosmetics
15Globally Harmonised System
- The basis for setting classification and
labelling has been harmonised to follow the UN
GHS criteria -
- The GHS system is made up of building blocks and
allows countries / regions to pick and chose
local systems with different regulatory basis
will result ? - Different hazard information for workers in
different regions of the world - Some countries (e.g. Japan) consider a risk based
approach for consumer product labelling under the
roof of the GHS, others do not ? - Different hazard information / warning
statements on the same consumer product in
different regions of the world
Globally Harmonised System ?
16Thank you very much for your attention
Avenue des Arts 6, B 1210 Bruxelles, Phone 32
2 214 2062, Email mvey_at_ifraorg.org
17Sensitisation to the Fragrance Mix I IVDK 2007
Basis Schnuch et al Contact Dermatitis, 50
65-76 (2004)
18IFRA Standards Recognition
- IFRA Standards are the only globally
acceptedrisk management system for fragrance
ingredients and receive high reputation from
customer and authority point of view. - Since 1990 the Brazilian regulation recognizes
the self-regulation of the industry by official
adoption of the IFRA Standards - IFRA Standards are about to be introduced in the
European Cosmetics law (IFRA prohibited already
included, IFRA restricted in the process). - The ASEAN Cosmetics Directive foresees a
requirement for proving IFRA compliance.